MAUDE Adverse Event Report: DKK SKYTRON; SURGICAL LIGHT

Model Number IF 22

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 07/19/2013

Event Type  Injury  

Event Description

Employees moved lights and it fell from bracket causing injury to employee's arm, shoulder, neck back.

Manufacturer Narrative

This is under investigation awaiting additional info from facility and distributor.

• Brand Name: SKYTRON
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): DKK; tokyo ; JA

tokyo 

• MDR Report Key: 3904725
• MDR Text Key: 4515248
• Report Number: 1825014-2014-00006
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IF 22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 05/13/2014
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1